Incorporation of healthy volunteers data on receptor occupancy into a phase II proof‐of‐concept trial using a Bayesian dynamic borrowing design
Fulvio Di Stefano,
Christelle Rodrigues,
Stephanie Galtier
et al.
Abstract:Receptor occupancy in targeted tissues measures the proportion of receptors occupied by a drug at equilibrium and is sometimes used as a surrogate of drug efficacy to inform dose selection in clinical trials. We propose to incorporate data on receptor occupancy from a phase I study in healthy volunteers into a phase II proof‐of‐concept study in patients, with the objective of using all the available evidence to make informed decisions. A minimal physiologically based pharmacokinetic modeling is used to model r… Show more
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